UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006207 |
|---|---|
| Receipt number | R000007339 |
| Scientific Title | Molecular alterations in Barrett's esophagus by the treatment with proton pump inhibitors or Helicobacter pylori eradication |
| Date of disclosure of the study information | 2011/08/21 |
| Last modified on | 2015/02/22 13:17:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Molecular alterations in Barrett's esophagus by the treatment with proton pump inhibitors or Helicobacter pylori eradication
Acronym
Molecular alterations in Barrett's esophagus and the treatment with PPIs or H. pylori eradication
Scientific Title
Molecular alterations in Barrett's esophagus by the treatment with proton pump inhibitors or Helicobacter pylori eradication
Scientific Title:Acronym
Molecular alterations in Barrett's esophagus and the treatment with PPIs or H. pylori eradication
Region
| Japan |
Condition
Condition
Barrett's esophagus
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the molecular alterations in Barrett's esophagus by the treatment with PPIs or H. pylori eradication
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes of biomarkers related to pathogenesis of Barrett's esophagus are evaluated at baseline and 1-yr after intervention with/without PPI administration in H. pylori negative patients and H. pylori eradication in H. pylori positive patients
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
H. pylori un-eradicated group (H. pylori positive case)
Interventions/Control_2
H. pylori eradicated group (H. pylori positive case)
Interventions/Control_3
PPI un-treated group (H. pylori negative case)
Interventions/Control_4
PPI treated group (H. pylori negative case)
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with Barrett's esophagus diagnosed by endoscopy
Key exclusion criteria
(1)Patients with malignancy in other organs
(2)Patients with having allergy to PPIs or drugs used for H. pylori eradication
(3)Patients who are regularly taking PPIs or non-steroidal anti-inflammatory drugs
(4)Past episode of H. pylori treatment
(5)Patients with having a past history of esophagectomy or gastrectomy
(6)Patients who have determined by the physicians to have any reasons of unqualified
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroto Miwa |
Organization
Hyogo College of Medicine
Division name
Division of Gastroenterology, Department of Internal Medicine
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798-45-6665
miwahgi@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jiro Watari |
Organization
Hyogo College of Medicine
Division name
Division of Gastroenterology, Department of Internal Medicine
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798-45-6662
Homepage URL
watarij@hyo-med.ac.jp
Sponsor or person
Institute
Division of Gastroenterology, Department of Internal Medicine, Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
兵庫医科大学病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2010 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 21 | Day |
Last modified on
| 2015 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007339
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
